scholarly journals Stay Present with Your Phone: A Systematic Review and Standardized Rating of Mindfulness Apps in European App Stores

2020 ◽  
Author(s):  
Dana Schultchen ◽  
Yannik Terhorst ◽  
Tanja Holderied ◽  
Michael Stach ◽  
Eva-Maria Messner ◽  
...  
Keyword(s):  
Information Quality ◽  
Rating Scale ◽  
Controlled Trial ◽  
Privacy Policy ◽  
Physical And Mental Health ◽  
Content Quality ◽  
Positive Effects ◽  
Potential Risks ◽  
And Behavior

Abstract Background Mindfulness-based interventions show positive effects on physical and mental health. For a better integration of mindfulness techniques in daily life, the use of apps may be promising. However, only a few studies have examined the quality of mindfulness apps using a validated standardized instrument. This review aims to evaluate the content, quality, and privacy features of mindfulness-focused apps from European commercial app stores. Methods An automated search engine (webcrawler) was used to identify mindfulness-focused apps in the European Apple App- and Google Play store. Content, quality, and privacy features were evaluated by two independent reviewers using the Mobile Application Rating Scale (MARS). The MARS assesses the subscales engagement, functionality, aesthetics, and information quality. Results Out of 605 identified apps, 192 met the inclusion criteria. The overall quality was moderate (M = 3.66, SD = 0.48). Seven apps were tested in a randomized controlled trial (RCT). Most of the apps showed a lack of data security and no privacy policy. The five apps with the highest ratings are from a credible source, include a privacy policy, and are also based on standardized mindfulness and behavior change techniques. Conclusions The plethora of often low-quality apps in commercial app stores makes it difficult for users to identify a suitable app. Above that, the lack of scientific verification of effectiveness and shortcomings in privacy protection and security poses potential risks. So far, the potential of mindfulness-focused apps is not exploited in commercial app stores.

Quality benchmarking of smartphone laboratory medicine applications: comparison of laboratory medicine specialists’ and non-laboratory medicine professionals’ evaluation

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Snežana Jovičić ◽  
Joanna Siodmiak ◽  
Marta Duque Alcorta ◽  
Maximillian Kittel ◽  
Wytze Oosterhuis ◽  
...  
Keyword(s):  
Information Quality ◽  
Rating Scale ◽  
Laboratory Medicine ◽  
Test Results ◽  
Content Quality ◽  
Laboratory Test Results ◽  
System Usability Scale ◽  
Mobile Health Applications ◽  
Fit For Purpose ◽  
Health Applications

AbstractObjectivesThere are many mobile health applications (apps) now available and some that use in some way laboratory medicine data. Among them, patient-oriented are of the lowest content quality. The aim of this study was to compare the opinions of non-laboratory medicine professionals (NLMP) with those of laboratory medicine specialists (LMS) and define the benchmarks for quality assessment of laboratory medicine apps.MethodsTwenty-five volunteers from six European countries evaluated 16 selected patient-oriented apps. Participants were 20–60 years old, 44% were females, with different educational degrees, and no professional involvement in laboratory medicine. Each participant completed a questionnaire based on the Mobile Application Rating Scale (MARS) and the System Usability Scale, as previously used for rating the app quality by LMS. The responses from the two groups were compared using the Mann-Whitney U test and Spearman correlation.ResultsThe median total score of NLMP app evaluation was 2.73 out of 5 (IQR 0.95) compared to 3.78 (IQR 1.05) by the LMS. All scores were statistically significantly lower in the NLMP group (p<0.05), except for the item Information quality (p=0.1631). The suggested benchmarks for a useful appear: increasing awareness of the importance and delivering an understanding of persons’ own laboratory test results; understandable terminology; easy to use; appropriate graphic design, and trustworthy information.ConclusionsNLMP’ evaluation confirmed the low utility of currently available laboratory medicine apps. A reliable app should contain trustworthy and understandable information. The appearance of an app should be fit for purpose and easy to use.

scholarly journals Correlations Between Clinical Trial Outcomes Based on Symptoms, Functional Impairments, and Quality of Life in Children and Adolescents With ADHD

2017 ◽  
Vol 23 (13) ◽  
pp. 1578-1591 ◽  
Author(s):  
David R. Coghill ◽  
Alain Joseph ◽  
Vanja Sikirica ◽  
Mark Kosinski ◽  
Caleb Bliss ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Children And Adolescents ◽  
Rating Scale ◽  
Controlled Trial ◽  
Pearson Correlation ◽  
Correlation Coefficients ◽  
Parent Report ◽  
Functional Impairments ◽  
Risk Avoidance

Objective: To assess relationships between treatment-associated changes in measures of ADHD symptoms, functional impairments, and health-related quality of life in children and adolescents with ADHD. Method: Pearson correlation coefficients were calculated post hoc for changes from baseline to endpoint in outcomes of one randomized, placebo- and active-controlled trial of lisdexamfetamine (osmotic-release methylphenidate reference) and one of guanfacine extended-release (atomoxetine reference). Results: Changes in ADHD Rating Scale IV (ADHD-RS-IV) total score generally correlated moderately with changes in Child Health and Illness Profile−Child Edition: Parent Report Form (CHIP-CE:PRF) Achievement and Risk Avoidance ( r ≈ .4), but weakly with Resilience, Satisfaction, and Comfort ( r ≈ .2); and moderately with Weiss Functional Impairment Rating Scale–Parent (WFIRS-P) total score ( r ≈ .5). CHIP-CE:PRF Achievement and Risk Avoidance correlated moderately to strongly with WFIRS-P total score ( r ≈ .6). Conclusion: The ADHD-RS-IV, CHIP-CE:PRF, and WFIRS-P capture distinct but interconnected aspects of treatment response in individuals with ADHD.

scholarly journals Effects of Dog-Assisted Therapy in Adolescents with Eating Disorders: A Study Protocol for a Pilot Controlled Trial

Animals ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. 2784
Author(s):  
Ana Myriam Lavín-Pérez ◽  
Cristina Martín-Sánchez ◽  
Beatriz Martínez-Núñez ◽  
Luis Lucio Lobato-Rincón ◽  
Santos Villafaina ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Eating Disorders ◽  
Pilot Study ◽  
Handgrip Strength ◽  
Controlled Trial ◽  
Self Esteem ◽  
Control Group ◽  
Physical And Mental Health ◽  
Anxiety Depression

Background: Eating disorders are characterized by a persistent disturbance that alters food intake and it is often accompanied by anxiety, depression, low self-esteem, or reduced functional capacity and quality of life. Animal-assisted therapies (AAT) have shown benefits in these variables in children and adult populations. Thus, the present pilot study will aim to evaluate the effects of a dog-assisted therapy on the eating disorders symptoms, mental, psychosocial, and physical health, quality of life, and handgrip strength of adolescents suffering from eating disorders. Methods: The current pilot study will involve 32 patients, who will be assigned to a control or an experimental group. Intervention will be conducted once a week for seven weeks. Neither the experimental nor the control group will discontinue their usual care. The main outcome measures will be the eating disorder symptoms and the health-related quality of life measured with standardized questionnaires, while the secondary variables will be anxiety, depression, character, behavior, strength, and body mass. Conclusions: This pilot-controlled trial will be the first to evaluate the effects of dog-assisted therapy on the physical and mental health of adolescents with eating disorders. Significant improvements, in the primary and secondary outcomes, may be expected based on the known benefits of AAT on self-esteem, stress, and self-control in different populations. Finally, although the program is focused on the improvement of adolescents’ health, animal welfare will be a priority in this study.

scholarly journals The Arabic Version of the Mobile App Rating Scale: Development and Validation Study (Preprint)

2019 ◽  
Author(s):  
Marco Bardus ◽  
Nathalie Awada ◽  
Lilian A Ghandour ◽  
Elie-Jacques Fares ◽  
Tarek Gherbal ◽  
...  
Keyword(s):  
Weight Management ◽  
Information Quality ◽  
Rating Scale ◽  
Arab World ◽  
Intraclass Correlation ◽  
Correlation Coefficients ◽  
Mobile App ◽  
Health Apps ◽  
Highly Correlated

BACKGROUND With thousands of health apps in app stores globally, it is crucial to systemically and thoroughly evaluate the quality of these apps due to their potential influence on health decisions and outcomes. The Mobile App Rating Scale (MARS) is the only currently available tool that provides a comprehensive, multidimensional evaluation of app quality, which has been used to compare medical apps from American and European app stores in various areas, available in English, Italian, Spanish, and German. However, this tool is not available in Arabic. OBJECTIVE This study aimed to translate and adapt MARS to Arabic and validate the tool with a sample of health apps aimed at managing or preventing obesity and associated disorders. METHODS We followed a well-established and defined “universalist” process of cross-cultural adaptation using a mixed methods approach. Early translations of the tool, accompanied by confirmation of the contents by two rounds of separate discussions, were included and culminated in a final version, which was then back-translated into English. Two trained researchers piloted the MARS in Arabic (MARS-Ar) with a sample of 10 weight management apps obtained from Google Play and the App Store. Interrater reliability was established using intraclass correlation coefficients (ICCs). After reliability was ascertained, the two researchers independently evaluated a set of additional 56 apps. RESULTS MARS-Ar was highly aligned with the original English version. The ICCs for MARS-Ar (0.836, 95% CI 0.817-0.853) and MARS English (0.838, 95% CI 0.819-0.855) were good. The MARS-Ar subscales were highly correlated with the original counterparts (<i>P</i>&lt;.001). The lowest correlation was observed in the area of usability (<i>r</i>=0.685), followed by aesthetics (<i>r</i>=0.827), information quality (<i>r</i>=0.854), engagement (<i>r</i>=0.894), and total app quality (<i>r</i>=0.897). Subjective quality was also highly correlated (<i>r</i>=0.820). CONCLUSIONS MARS-Ar is a valid instrument to assess app quality among trained Arabic-speaking users of health and fitness apps. Researchers and public health professionals in the Arab world can use the overall MARS score and its subscales to reliably evaluate the quality of weight management apps. Further research is necessary to test the MARS-Ar on apps addressing various health issues, such as attention or anxiety prevention, or sexual and reproductive health.

Intensive versus minimalist follow-up in patients treated for endometrial cancer: A multicentric randomized controlled trial (The TOTEM study—NCT00916708).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5506-5506
Author(s):  
Paolo Zola ◽  
Giovannino Ciccone ◽  
Elisa Piovano ◽  
Luca Fuso ◽  
Elena Peirano ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Overall Survival ◽  
Endometrial Cancer ◽  
Cancer Patients ◽  
Early Recognition ◽  
Controlled Trial ◽  
Physical And Mental Health ◽  
Randomized Controlled

5506 Background: Intensive follow-up in cancer patients, which absorbs a lot of health system resources and can be a source of increased stress for patients, are often proposed on the assumption that an early recognition of relapse will translate in better outcomes. In endometrial cancer few randomized controlled trials were conducted to assess the role of a reduced number of the scheduled visits and of different settings of the follow-up, but did not investigate the contribution of routine serum, cytological or imaging follow-up investigations in improving overall survival or quality of life. The TOTEM study was planned to compare an intensive (INT) vs minimalist (MIN) 5- year follow-up regimen in endometrial cancer patients in terms of overall survival (OS). Methods: Patients surgically treated for endometrial cancer, in complete clinical remission confirmed by imaging, FIGO stage I-IV, were stratified by center and in low (LoR) or high (HiR) risk of recurrence and then randomized to INT or MIN hospital-based follow-up regimens. The main study hypothesis was to demonstrate an improvement from 75% to 80% (expected hazard ratio, HR = 0.78) of the 5-year OS with the INT regimen. Secondary objectives were to compare relapse free survival (RFS), health-related quality of life (HRQL) assessed at baseline, at 6 and 12 months and then yearly (with the SF-12 Physical and Mental Health Summary Scale) and costs. Results: 1884 patients were randomized in 42 centers between 2008 and 2018, and 1847 patients were available for the final analysis (60% LoR). Compliance with the follow-up scheduled visits was 75.3%, similar between INT (74.7%) and MIN (75.9%) arms, whereas the mean number of recorded exams (laboratory or imaging) was markedly higher in the INT than in the MIN arms (9.7 vs 2.9, p < 0.0001). After a median follow-up of 66 months, the overall 5-year OS was 91.3%, 90.6% in the INT and 91.9% in the MIN arms, respectively (HR = 1.12, 95%CI 0.85-1.48, p = 0.429). Comparing the INT vs MIN arms, the 5-year OS were 94.1% and 96.8% (HR = 1.48, 0.92-2.37, p = 0.104) in the LoR and 85.3% and 84.7% (HR = 0.96, 0.68-1.36, p = 0.814) in the HiR group. No relevant differences emerged in RFS between INT and MIN regimens, (HR = 1.13, 0.87-1.48, p = 0.365). At the time of the relapse most women were asymptomatic (146/228, 64.0%), with a tendency of higher proportions in the INT than in the MIN arm, both in the LoR group (78.8% vs 61.1%, p = 0.070) and in the HiR one (64% vs 60%, p = 0.754). HRQL was available only for a subgroup of patients (50% at baseline) and did not differ between arms. Conclusions: Intensive follow-up in endometrial cancer treated patients showed a weak and uncertain advantage in detecting earlier asymptomatic relapses but did not improve OS, even in HiR patients, nor influenced HRQL. Frequent routine use of imaging and laboratory exams in these patients should be discouraged. Clinical trial information: NCT00916708.

scholarly journals Effect of probiotics on nasal and intestinal microbiota in people with high exposure to particulate matter ≤ 2.5 μm (PM2.5): a randomized, double-blind, placebo-controlled clinical study

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Yongcan Wu ◽  
Caixia Pei ◽  
Xiaomin Wang ◽  
Mingjie Wang ◽  
Demei Huang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Intestinal Microbiota ◽  
Rating Scale ◽  
Short Form ◽  
Controlled Trial ◽  
High Exposure ◽  
Gastrointestinal Symptom Rating Scale ◽  
Probiotic Treatment ◽  
High Concentrations

Abstract Background Extended exposure to high concentrations of PM2.5 changes the human microbiota profile, which in turn may increase morbidity and mortality due to respiratory system damage. A balanced microecosystem is crucial to human health, and certain health-related problems may be addressed by effective microecosystem regulation. Recent studies have confirmed that probiotics may reduce the incidence of respiratory diseases. However, few studies have investigated probiotic treatment outcomes in subjects exposed to high concentrations of PM2.5. Methods This study is designed as a prospective, randomized, participants- and assessor-blinded, placebo-controlled trial. One hundred and twenty eligible volunteers recruited from October 2019 to July 2020 in downtown Chengdu, China, will be treated with either probiotics or placebo over 4 consecutive weeks. The primary outcome will be 16SrRNA sequencing assay data from nasal and intestinal secretions. Secondary outcomes will be pulmonary function, score on a gastrointestinal symptom rating scale, COOP/WONCA charts, and the Short-Form Health Survey 36 for quality of life. Results will be analyzed to assess differences in clinical efficacy between groups. Six-month follow-up examinations will evaluate the long-term value of probiotics on cardiovascular and respiratory disease end-point events. Discussion We will explore the characteristics of nasal and intestinal microbiota in a population with high exposure to PM2.5. Probiotics and placebo interventions will be tested for efficacy in microbial balance regulation, effects on lung and physical functions, and quality of life improvement. This study is expected to provide reliable evidence to support the widespread promotion of probiotics in clinical practice for the protection of individuals with high exposure to PM2.5. Trial registration Chinese Clinical Trial Registry ChiCTR1900025469. Registered on 27 August 2019.

scholarly journals A Randomized, Placebo-Controlled Trial Evaluating Changes in Peripheral Neuropathy and Quality of Life by Using Low-Frequency Electrostimulation on Breast Cancer Patients Treated With Chemotherapy

2020 ◽  
Vol 19 ◽  
pp. 153473542092551
Author(s):  
Si-Yeon Song ◽  
Ji-Hye Park ◽  
Jin Sun Lee ◽  
Je Ryong Kim ◽  
Eun Hee Sohn ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Peripheral Neuropathy ◽  
Rating Scale ◽  
Controlled Trial ◽  
Low Frequency ◽  
Pharmacological Intervention ◽  
European Organization ◽  
Eortc Qlq

Background: This study examined the effect of a portable low-frequency electrostimulation (ES) device on patients diagnosed with chemotherapy-induced peripheral neuropathy (CIPN) immediately after chemotherapy for breast cancer. Methods: A single-center, randomized, placebo-controlled trial was conducted. A total of 72 patients newly diagnosed with CIPN were enrolled and randomly placed into the ES (n = 36) or the sham ES group (SES; n = 36). Duloxetine or pregabalin was prescribed to all participants from the initial assessment. The devices for 14 days, at least twice a day, for at least 120 minutes. The primary outcomes were the overall intensities of the CIPN symptoms as assessed using Numerical Rating Scale (NRS). Secondary outcomes included Total Neuropathy Score (TNS), European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QLQ), Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20), Functional Assessment of Cancer Therapy-Breast (FACT-B), and Instrument on Pattern Identification and Evaluation for CIPN (IPIE-CIPN). Results: No differences in NRS scores were found between the patients in the ES and the SES group ( P = 0.267). Patients in both groups showed significantly reduced CIPN intensities (ES P < .001; SES P < .001). No significant differences between the groups were found in TNS, EORTC-QLQ, CIPN20, and FACT-B. The general symptoms of CIPN diagnosed as cold arthralgia showed significance only in the ES group ( P = .006). Conclusion: Compared with a placebo, the effectiveness of the low-frequency ES device with pharmacological intervention was not significantly different, but a therapeutic effect was possible.

Effect of Pregabalin on Radiotherapy-Related Neuropathic Pain in Patients With Head and Neck Cancer: A Randomized Controlled Trial

2019 ◽  
Vol 37 (2) ◽  
pp. 135-143 ◽  
Author(s):  
Jingru Jiang ◽  
Yi Li ◽  
Qingyu Shen ◽  
Xiaoming Rong ◽  
Xiaolong Huang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Adverse Event ◽  
Neuropathic Pain ◽  
Rating Scale ◽  
Short Form ◽  
Controlled Trial ◽  
Numeric Rating Scale ◽  
Mood States ◽  
Numeric Rating

Purpose Neuropathic pain is an unavoidable treatment-related adverse event among patients with head and neck cancer who are undergoing radiotherapy. We aimed to test the efficacy and safety of pregabalin versus placebo in the treatment of radiotherapy-related neuropathic pain. Patients and Methods This randomized, double-blind, placebo-controlled trial was conducted in four centers in China. Eligible patients with a mean pain intensity score of 4 or more on an 11-point numeric rating scale were randomly assigned to receive either active treatment with a flexible dose of pregabalin or placebo for 16 weeks. The primary efficacy outcome was pain reduction measured on the numeric rating scale. Result There were 128 patients who received treatment as randomly assigned. Pain intensity reduction was 2.44 in the pregabalin arm and 1.58 in the placebo arm at week 16, yielding an adjusted mean difference of 0.87 (95% CI, 0.30 to 1.44; P = .003). In the pregabalin arm, 38 patients (59.4%) achieved at least 30% pain relief versus 21 (32.8%) in the placebo arm ( P = .006). Nineteen patients (29.7%) in the pregabalin group and five (7.8%) in the placebo group achieved 50% or greater pain relief ( P = .003). Total scores on the Profile of Mood States-Short Form, pain severity and functional interference of Brief Pain Inventory-Short Form, as well as the physiology and psychology domain of the WHO Quality of Life-BREF all were reduced significantly at week 16 in patients who received pregabalin compared with those who received placebo. There was no significant difference ( P = .29) in the incidence of experiencing at least one adverse event in the pregabalin arm (n = 35; 54.7%) versus the placebo arm (n = 29; 45.3%). Conclusion Patients treated with pregabalin with radiotherapy-related neuropathic pain had greater pain alleviation, better mood states, and higher quality of life compared with patients in the placebo group, with a good tolerability.

scholarly journals Toward Gamified Pain Management Apps: Mobile Application Rating Scale–Based Quality Assessment of Pain-Mentor’s First Prototype Through an Expert Study

10.2196/13170 ◽  
2020 ◽  
Vol 4 (5) ◽  
pp. e13170
Author(s):  
Alexandra Hoffmann ◽  
Corinna A Faust-Christmann ◽  
Gregor Zolynski ◽  
Gabriele Bleser
Keyword(s):  
Chronic Pain ◽  
Pain Management ◽  
Mobile Application ◽  
Rating Scale ◽  
Pain Treatment ◽  
Semistructured Interview ◽  
Content Quality ◽  
Management Techniques ◽  
Health Experts

Background The use of health apps to support the treatment of chronic pain is gaining importance. Most available pain management apps are still lacking in content quality and quantity as their developers neither involve health experts to ensure target group suitability nor use gamification to engage and motivate the user. To close this gap, we aimed to develop a gamified pain management app, Pain-Mentor. Objective To determine whether medical professionals would approve of Pain-Mentor’s concept and content, this study aimed to evaluate the quality of the app’s first prototype with experts from the field of chronic pain management and to discover necessary improvements. Methods A total of 11 health professionals with a background in chronic pain treatment and 2 mobile health experts participated in this study. Each expert first received a detailed presentation of the app. Afterward, they tested Pain-Mentor and then rated its quality using the mobile application rating scale (MARS) in a semistructured interview. Results The experts found the app to be of excellent general (mean 4.54, SD 0.55) and subjective quality (mean 4.57, SD 0.43). The app-specific section was rated as good (mean 4.38, SD 0.75). Overall, the experts approved of the app’s content, namely, pain and stress management techniques, behavior change techniques, and gamification. They believed that the use of gamification in Pain-Mentor positively influences the patients’ motivation and engagement and thus has the potential to promote the learning of pain management techniques. Moreover, applying the MARS in a semistructured interview provided in-depth insight into the ratings and concrete suggestions for improvement. Conclusions The experts rated Pain-Mentor to be of excellent quality. It can be concluded that experts perceived the use of gamification in this pain management app in a positive manner. This showed that combining pain management with gamification did not negatively affect the app’s integrity. This study was therefore a promising first step in the development of Pain-Mentor.

scholarly journals Efficacy of a complex intervention comprising the guideline evidence-based health information and a training programme on the quality of health information: study protocol of a randomised controlled trial

2020 ◽  
Author(s):  
Julia Lühnen ◽  
Birte Berger-Höger ◽  
Burkhard Haastert ◽  
Jana Hinneburg ◽  
Jürgen Kasper ◽  
...  
Keyword(s):  
Health Information ◽  
Evidence Based Medicine ◽  
Information Quality ◽  
Controlled Trial ◽  
Training Programme ◽  
Control Group ◽  
Evidence Based ◽  
Study Results ◽  
Based Medicine

Abstract Background Evidence-based health information (EBHI) is a prerequisite for informed and shared decision-making. The criteria for EBHI have been described comprehensively but the implementation in practice is still insufficient. The guideline evidence-based health information addresses providers of health information. Its goal is to improve the quality of health information. The evidence-based guideline emerged from the German Network for Evidence-based Medicine (DNEbM) and was published in February 2017. In addition, the competences of providers of health information were explored and a training programme was developed. Aim of this study is to evaluate the efficacy of a training programme addressing providers of health information to support the application of the guideline evidence-based health information. We expect the intervention to improve the quality of health information in comparison to provision of the guideline only. Methods The trial uses a superiority randomised control group design with ten months follow-up. 26 providers of health information (groups with up to ten members) will be enrolled to compare the intervention (guideline & training programme) with usual care (guideline publicly available). The 5-day training programme comprises an evidence-based medicine training module and a module to prepare the application of the guideline. The primary outcome parameter is the quality of the health information. Quality is operationalised as the extent of adherence to the guideline’s recommendations. Each provider will prepare a single health information informing a health-related decision on a freely chosen topic. The quality of this information will be rated using the Mapping Health Information Quality (MAPPinfo) checklist. An accompanying process evaluation will then be conducted. Discussion The study results will show whether the efficacy of the intervention justifies implementation of the training programme to enhance health information developers’ competences in evidence-based medicine and to ensure high quality EBHI in the long-term. Trial registration ISRCTN registry, registration number: ISRCTN96941060, Date: 7 March 2019, URL: http://www.isrctn.com/ISRCTN96941060

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